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This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. The procedures used to Annex H, “Guidance on risk management for in vitro diagnostic medical devices”, was prepared by ISO/TC 212, Clinical laboratory testing and in vitro diagnostic The broader context of BS EN ISO 14971 and its use in conjunction with other international standards to demonstrate compliance with regulatory requirements isThe process described in this document applies to risks associated with a medical device, such as risks related. Page 10. WWW.GREENLIGHT.GURU. PAGE 9. ISO 14971